Ziprasidone for Improving Insulin Sensitivity in People With Schizophrenia Who Are at Risk for Diabetes

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jonathan M. Meyer, MD, Veterans Medical Research Foundation
ClinicalTrials.gov Identifier:
NCT00338949
First received: June 16, 2006
Last updated: August 6, 2013
Last verified: August 2013

June 16, 2006
August 6, 2013
June 2006
December 2009   (final data collection date for primary outcome measure)
  • Insulin sensitivity [ Time Frame: Measured at Week 26 ] [ Designated as safety issue: No ]
  • Visceral fat mass [ Time Frame: Measured at Week 26 ] [ Designated as safety issue: No ]
  • Total adiposity [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Measured at Week 26: Insulin sensitivity
  • Visceral fat mass
  • Total adiposity
Complete list of historical versions of study NCT00338949 on ClinicalTrials.gov Archive Site
  • Body mass index [ Time Frame: Measured at Week 26 ] [ Designated as safety issue: No ]
  • Fasting glucose [ Time Frame: Measured at Week 26 ] [ Designated as safety issue: No ]
  • Fasting lipids [ Time Frame: Measured at Week 26 ] [ Designated as safety issue: No ]
  • Fasting insulin [ Time Frame: Measured at Week 26 ] [ Designated as safety issue: No ]
  • Total psychiatric hospital days [ Time Frame: Measured at Week 26 ] [ Designated as safety issue: Yes ]
  • Measured at Week 26: Body mass index
  • Fasting glucose
  • Fasting lipids
  • Fasting insulin
Not Provided
Not Provided
 
Ziprasidone for Improving Insulin Sensitivity in People With Schizophrenia Who Are at Risk for Diabetes
The Metabolic Syndrome in Patients With Schizophrenia

This study will evaluate the effectiveness of ziprasidone treatment versus treatment with a standard atypical antipsychotic drug in improving insulin sensitivity and reducing excess abdominal fat storage in people with schizophrenia who are at risk for diabetes.

People with schizophrenia often lead more sedentary lifestyles than people without the disease, and they are frequently treated with antipsychotic medications that cause weight gain. Combined, these factors produce an increased risk for metabolic syndrome, which can lead to heart disease and type 2 diabetes. Characteristics of metabolic syndrome include carrying excess weight around the abdominal region; high blood pressure; high blood sugar levels; high levels of fat in the blood; and low levels of HDL cholesterol. Recent studies have shown that certain atypical antipsychotic drugs are relatively weight-neutral. Switching from a drug that promotes weight gain to a weight-neutral medication, such as ziprasidone, may result in significant weight loss. There is insufficient evidence, however, demonstrating the extent of improvement in insulin sensitivity after switching medications. This study will evaluate the effectiveness of ziprasidone treatment versus treatment with a standard atypical antipsychotic drug in improving insulin sensitivity and reducing excess abdominal fat storage in people with schizophrenia who are at risk for diabetes.

Participants in this open label study will currently be undergoing treatment with risperidone or olanzapine at the time of study entry. Upon study entry, they will be randomly assigned to either switch to ziprasidone treatment or remain on their current medications. Both groups will be treated for 26 weeks. Participants will report to the study site for evaluations biweekly until week 10 and then monthly for the duration of the study. The following outcomes will be assessed at study entry and Week 26: insulin sensitivity, using an intravenous glucose tolerance test; visceral fat mass, using a CT scan; and total adiposity, using a dexascan.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Schizophrenia
  • Metabolic Syndrome X
  • Insulin Resistance
  • Drug: Ziprasidone
    Participants who are switched to ziprasidone will take a max daily dose of 200 mg, flexibly dosed based on symptoms and adverse effects.
  • Drug: Standard atypical antipsychotic drug
    Participants will remain taking the same medications of risperidone or olanzapine as they were before study entry.
  • Active Comparator: Control
    Participants on risperidone or olanzapine who will remain on risperidone or olanzapine and do not switch to ziprasidone
    Intervention: Drug: Standard atypical antipsychotic drug
  • Experimental: Switch
    Participants who enter on risperidone or olanzapine and switch to ziprasidone
    Intervention: Drug: Ziprasidone
McEvoy JP, Meyer JM, Goff DC, Nasrallah HA, Davis SM, Sullivan L, Meltzer HY, Hsiao J, Scott Stroup T, Lieberman JA. Prevalence of the metabolic syndrome in patients with schizophrenia: baseline results from the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) schizophrenia trial and comparison with national estimates from NHANES III. Schizophr Res. 2005 Dec 1;80(1):19-32. Epub 2005 Aug 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
77
December 2009
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of schizophrenia or schizoaffective disorder
  • Currently receiving antipsychotic therapy with risperidone or olanzapine
  • Overweight

Exclusion Criteria:

  • Diagnosis of diabetes
  • Hospitalization for schizophrenia or schizoaffective disorder within 90 days prior to study entry
  • Refractory schizophrenia or schizoaffective disorder
  • Currently receiving therapy with clozapine
  • No stable residence and phone number for 90 days prior to study entry
  • Prior unsuccessful treatment with ziprasidone
  • Intolerance to ziprasidone
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00338949
K23 MH074540, K23MH074540, DATR AK-TNET1
No
Jonathan M. Meyer, MD, Veterans Medical Research Foundation
Veterans Medical Research Foundation
National Institute of Mental Health (NIMH)
Principal Investigator: Jonathan M. Meyer, MD University of California, San Diego & VA San Diego Healthcare System
Veterans Medical Research Foundation
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP